Corbus Pharmaceuticals Holdings, Inc.CRBPNASDAQ
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Operator: Hello, and welcome to the Corbus Pharmaceuticals Fourth Quarter and Year-End 2020 Earnings Conference Call. As a brief reminder, all participants are currently in a listen-only mode. . Following the presentation, there will be a question-and-answer session. Note that this conference call is being recorded at the company's request and will be made available on the company's website following the end of the call. I would now like to turn the conference over to your host, Ted Jenkins, Senior Director, Investor Relations and Corporate Communications. Please go ahead, sir.
Ted Jenkins: Thank you, operator, and good morning, everyone. Thank you for joining us today. At this time, I'd like to remind our listeners that remarks made during this call state management's intentions, hopes, beliefs, expectations or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws. These forward-looking statements are based on Corbus' current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports Corbus files with Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Joining me on the call today are Dr. Yuval Cohen, our Chief Executive Officer; Dr. Barbara White, our Chief Medical Officer and Head of Research; Sean Moran, our Chief Financial Officer; and Craig Millian, our Chief Commercial Officer. With that, it's now my pleasure to turn the call over to Yuval.
Yuval Cohen: Thank you, Ted. Good morning, and thank you to all of you joining us this morning. Since we reported clinical data last year, we have made progress on executing our strategic plan I laid out on the last quarter's call. First, we continue to work to maximize the value of lenabasum; second, we are working to move our internal pipeline into clinical testing in 2022; third, we are actively engaging with potential partners to expand our pipeline. Analyses of preclinical and clinical data show lenabasum is an active compound. As such, we believe our Phase 3 study in dermatomyositis represents a potentially significant inflection point in the coming months. We have executed our previously announced plan to move the primary endpoint from week 52 to week 28. All patients in the studies have now completed the week 28 visit. Topline data remains on track for the second quarter of this year. The data from this study will shape our path forward on lenabasum. We continue to advance and prioritize our in-house endocannabinoid system targeting assets, which Barbara will discuss today. We remain in a unique position being on the forefront of research and development of molecules that target this biology that has applicability across many potential indications. This pipeline encompasses drug candidates for metabolic disorders, fibrotic diseases and cancer. We anticipate that lead compounds from these internal programs will start clinical studies in 2022. The third element of our strategy is to expand our pipeline through acquisitions of external assets. We are focusing on biology beyond the endocannabinoid system and new indications that will leverage our expertise and capabilities within immunology.
Barbara White: Thank you, Yuval. The Phase 3 DETERMINE study, which is testing safety and efficacy of lenabasum in adult patients with dermatomyositis is progressing on schedule. As Yuval said, we amended the protocol to change the timing of the primary efficacy endpoint from week 52 to week 28. As a reminder, the primary efficacy endpoint is the composite ACR EULAR total improvement score comparing lenabasum 20 milligrams twice daily and placebo groups. In this study, lenabasum and placebo are added on to stable doses of standard treatments for dermatomyositis, including immunosuppressive therapies. All subjects in the DETERMINE study have completed their week 28 visits, and most have completed a 28-day safety follow-up visit off study drug. Topline results are expected in the second quarter of this year. The outcome of the DETERMINE study will inform our decision about next steps in our systemic sclerosis program. Forced vital capacity is being measured in these dermatomyositis subjects over the course of the study. We note with interest that Roche’s Actemra was approved by the FDA for the treatment of interstitial lung disease in systemic sclerosis recently, despite failing to meet the primary efficacy endpoint in both the Phase 2 and Phase 3 study. The approval appeared to be based on findings of less decline in forced vital capacity and post-hoc analysis of subgroups of the systemic sclerosis subjects. We are considering potential implications for the lenabasum program, in which less decline in forced vital capacity was also observed in a subgroup of subjects in that study. Currently, we are not considering additional studies of lenabasum in cystic fibrosis. We are working with investigators on post-hoc analysis of the data to better understand pulmonary exacerbations in people with cystic fibrosis who are at high-risk for these medically significant events. We want to take this opportunity to reiterate our gratitude to the leadership of the cystic fibrosis foundation, staff at the Cystic Fibrosis Foundation Therapeutics Incorporated, all our investigators, and especially, all the patients who participated in these studies for their support throughout our two Phase 2 studies in cystic fibrosis. This is an incredible community.
Yuval Cohen: Thank you, Barbara. I will now provide an update regarding our financial position. Corbus has significantly strengthened its balance sheet. We expect the cash on hand of approximately $127 million as of March 15, 2021 to fund operations into the first quarter of 2024 based on our current budget. This should allow us to complete our dermatomyositis study, move our 2 internal programs into the clinic next year and pursue complementary external opportunities without a financing overhang. In closing, we continue to believe that the endocannabinoid system is a key target for the development of therapeutics for the treatment of inflammatory fibrotic and metabolic diseases as well as cancer. We are excited for the completion of our Phase 3 clinical trials in dermatomyositis this year. We also look forward to data from the study of lenabasum in lupus. We are actively advancing our pipeline to focus on those programs that we can deliver at the earliest data inflection point. We have the resources, and are committed to bringing in external assets that complement our existing pipeline and expertise. We look forward to updating you on those initiatives in the very near future.
Operator: . Our first question today is from Brian Abrams of RBC Capital Markets.
David Szeto : This is David Szeto on for Brian. I just have a couple, another quick here. So first one, I was just wondering if you could elaborate maybe a little more on maybe how comfortable you're getting towards selecting candidates for both the CB1 and CB2 programs? I know that you mentioned you'll go into more details at a future R&D Day. But I guess just given the economy of sciences data they presented, it does look like you're starting to clearly differentiate some of the profiles and I guess, I'm just curious if you can provide any more color on kind of how comfortable you are reaching a profile that's desirable? And then my second question is just on cash runway. So it looks like the $127 million that you mentioned just now should last potentially 12 or so quarters through 1Q 2024, which maybe a flat run rate of just around $10 million for OpEx per quarter. I guess, could you remind us how that comes down from the $21 million last quarter? And if this take into account anything for entering the clinic with additional molecules in 2022 and beyond?
Barbara White: Okay. I'll take the first question, which was I think about our level of comfort that we'll be able to reach candidate selection with the CB1 inverse agonist and the CB2 agonist. Let me start with the CB1 inverse agonist. For us, I think there's just so much data that show the metabolic effects of these compounds in animals and in humans. And we've been able to confirm that with some of our candidates as well. So I suspect that the ability to show desired metabolic activity is not going to be an issue. The real question is to do our very best to minimize the levels of CB1 receptor occupancy in the brain with the compounds. And we have spent a lot of time testing a lot of compounds and redesigning compounds in order to be able to do that. And at this point, based on data that we have with some chronic dosing, 28-day dosing, in mice, we really have several promising compounds. So while those tests are ongoing, and we need to get into them in even more detail, at this point, I'm actually quite confident that we're going to get there, and we intend to get there by the end of the year, perhaps before the very end of the year. So things are progressing nicely in terms of our ability to understand the pharmacokinetics of these compounds in the brain as well as to move forward with the metabolic studies.
Sean Moran: So regarding cash -- Sean Moran, CFO. So we just completed 2 pivotal studies, very expensive in CF and SSC. So those costs were reflected in last year's burn rates and DM has just finished up. The other thing to keep in mind is we went through a reduction in workforce that really cut our personnel costs. So we do project about a $10 million burn on average going forward with our cash, and that will fund the development of our compounds into Phase 1 studies as well.
Operator: The next question is from Maury Raycroft of Jefferies.
Maurice Raycroft: So first question is on the dermatomyositis study. Just wondering if you could say how many patients have gone on to the open-label extension and are still on drug and if you can talk about discontinuation rate in the study, too? And potentially, anything that you're seeing in the open-label extension study that you can comment on at this point?
Barbara White: Sure, Maury. This is Barbara. Thanks for the question. Some numbers. We have had a discontinuation rate of around 8% from the study, which was a bit lower than we had anticipated. We have had, I think, 166 patients complete the week 28 visit, which is now the primary efficacy endpoint. We anticipate having, perhaps about 100 patients, give or take a few, complete the visit 10 by the time the study is actually shut down. And we have had of those that are eligible, 90% of the subjects who have been eligible so far have enrolled in the open-label extension. Does that help? Any other numbers?
Maurice Raycroft: Yes, that's helpful. And then the other question was just based on Actemra approval and you commented a little bit about it on the call, but just wondering if you can provide more on what next specific steps are and potentially even a little bit more on timeline. I guess, what else do you need to do in order to see if your SSC data could be sufficient to approach FDA? And is it contingent on what you see in the dermatomyositis study?
Barbara White: So I think, Maury, as you know, that we found the approval of Actemra for the treatment of interstitial lung disease in systemic sclerosis of great interest because that study -- that drug had failed. Had 2 negative studies, Phase 2 and a Phase 3 with not meeting the primary endpoints. But they did have, I think, really encouraging data in forced vital capacity. It is our understanding that the FDA actually requested the data. We certainly don't know that. We're not privy to that. But think that, that may be the case. And then looked at a subset of wasn't even a secondary analysis in the first Phase 2 study. So it was a great interest that a drug that approved under those circumstances, which I think points out the need for more treatments for this very severe autoimmune disease. So it makes us look at our data a couple of -- twice or 3 or 4 or 20 times because we also saw an effect -- a less decline in forced vital capacity in the patients who've been on stable immunosuppressants. The other thing about the Actemra data was those patients were not receiving what one would consider now standard of care. In fact, they were on no background immunosuppressants or a low dose of corticosteroids, which is really not what the treatment is for interstitial lung disease, was our patients were on standard treatment, and we were able to also see an impact on for passing those people who are on stable doses. There had been on it for an established period of time a couple of years. And so we also see the same kind of improvement. Our numbers are smaller. And we want to look for supportive data. And we think there can be supportive data that might come from open-label expansions, people who switched over to placebo. When we look and see how much improvement continues over time, is it durable? And from the dermatomyositis study because we are measuring forced vital capacity there. A smaller percentage of the patients have interstitial lung disease. It's about 38%, I believe, in our DM study. We are going to be very eager to see what change in forced vital capacity looks like in those patients, lenabasum versus placebo when they've been on stable immunosuppressant. So the timelines for doing that will be after we get the DM data, after we get the additional data analysis done, then we will see if we think it's worthwhile. It's hard to know if this FDA decision was a one-off or is it -- or if it signals some sort of change in willingness to consider subset analysis to prove drugs in this rare disease.
Maurice Raycroft: Got it. That's really helpful perspective. So it sounds like potentially the next update on this potential path would be in the second half this year?
Barbara White: I think that's fair, by the time we get the DM data and look through everything else because getting the DM data is going to be our first priority right now.
Operator: Thank you. We have reached the end of our question-and-answer session. Ladies and gentlemen, that concludes today's teleconference and webcast. We thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.